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Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices

Study acronym: SECURE
StatusActive, Not Recruiting
PhasePhase 4
Started2023-03-09
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 18, 2024 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-11-14
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 130→confirmed 20
Study sitesdetails revised at 8 of 8 sites
2024-01-16
minor
Study Status, Eligibility, Contacts/Locations v7
Eligibility criteria-244 characters
[...] therapy prescribed for a long time, for at least 72 hours. Post beta2-mimetic reversibility of at least 200 ml and 12% of Forced Expiratory Volume 1 at inclusion or in history. High dose inhaled corticosteroid therapy (> 800 μg / d budes [...] re than 10 pack-years Exacerbation in the 4 weeks preceding inclusion or first Mepolizumab injection In case of exacerbation, the patient can only be included in the study 4 weeks after the end of the exacerbation Patient who has already been treated with Mepolizumab or an [...]
Study sitescontacts updated at 1 of 8 sites
2023-09-21
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 8 sites
2023-06-19
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v5
Completion date2026-03→2026-07
Eligibility criteria+67 characters
[...] ist and followed for at least a year Blood eosinophilia ≥ 0.315 G / L in the 12 months preceding inclusion in the trial. At [...] at inclusion) or breastfeeding Active smoking or ex-smoking for less than 6 months and more than 10 pack-years Exacerbation in the 4 weeks precedi [...] another anti-IL-5 or -5R treatment Patient currently using anya biotherapiesbiotherapy indicated in severe asthma other than anti-IL5 or immunosuppressive5R treatments (exceptor oral corticoids indicatedstopped for asthmaless treatment)than 2 months Treatment underway with another biotherapy not indicated for severe asthma Pati [...] [...]
Secondary endpoints15 to 17 entries
Compare the patients' quality of life in each group dyspnea
Study sitesdetails revised at 1 of 8 sites
2023-06-09
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 8 sites
Show 3 earlier versions
2023-05-15
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 8 sites
2023-03-10
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03→confirmed 2023-03-09
Study sitesdetails revised at 8 of 8 sites
2023-03-02
minor
Study Status v1
Primary completion date2025-11→2026-03
Completion date2025-11→2026-03
Start date2022-11→2023-03
2022-11-15
minor
Original filing
Asthma is a common pathology, with a prevalence of 6 to 8% and more than 4 million patients in France. Its management is based on different therapeutic axes. Their use is very dependent on disease control, with therapeutic escalation, from treatment on demand to a combination of them at high dosage, according to the severe asthma's phenotype. Despite these effective therapeutic tools, there is a lack of control of the disease in the vast majority of cases, affecting at least 60% of asthmatics. Among the factors associated with lack of control, non-compliance with inhaled therapies is frequent and requires to be systematically assessed in the absence of control. Its evaluation by definition is complex and variously appreciated, fluctuating from 40 to 80%. The means proposed for evaluating it involve doctor/patient interviews, evaluation of the therapeutic response, questionnaires, evaluation of drug consumption (evaluation of number of empty boxes, integrated electronic device, withdrawal of drugs from pharmacies, etc). Asthma control is commonly evaluated using the validated Asthma Control Test score, in clinical practice and/or in research fields. An ACT score greater than 20 indicates well-controlled asthma. In addition, a change of at least 3 points is likely to indicate a clinically meaningful change in asthma control (Minimally Clinical Important Difference) in an individual patient over time and a change of 4 points or more further reduces the risk that the change is due to measurement error. In the context of severe eosinophilic asthma, Mepolizumab has shown its benefit in controlling asthma, reducing the number of exacerbations and its ability to decrease the use of oral corticosteroids (MENSA, SIRIUS). Mepolizumab is now available in 2 new "ready-to-use" forms: a pre-filled syringe and an auto-injector pen. Both systems can be administered at home either by a nurse or by the patient himself (self-administration). The choice is left to the discretion of the prescribing pulmonologist. These new possibilities of Mepolizumab administration offer greater freedom to the patient, possibly allowing him to empower himself by carrying out his own treatment, without constraint and without being dependent on the availability of a nurse or another healthcare professional qualified to inject Mepolizumab. These new methods of Mepolizumab self- administration also open the field to therapeutic non-compliance, a new problem in the field of biotherapies used for the treatment of severe asthma. The investigator hypothesize a potential therapeutic non-compliance associated with the new method of administration of Mepolizumab, with self-injection by the patient, without the assistance of a nurse. To assess this problem, the investigator propose to compare in a therapeutic trial Mepolizumab administered by pre-filled syringe by a home nurse every month versus Mepolizumab self-administered by auto-injector pen by the patient every month.
Trial Details
NCT Number NCT05626777
Lead Sponsor Hospices Civils de Lyon
Collaborators: GlaxoSmithKline
Conditions Asthma
Enrollment 20 participants
Start Date 2023-03-09
Primary Completion 2026-03 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2024-11-18